Performances of the BD MAX™ CDIFF assay for the detection of toxigenic Clostridioides difficile using Cary-Blair preserved samples

Diagn Microbiol Infect Dis. 2022 Jul;103(3):115701. doi: 10.1016/j.diagmicrobio.2022.115701. Epub 2022 Apr 22.

Abstract

Toxigenic Clostridioides difficile infection (CDI) is a high concern because of its increasing prevalence, among both nosocomial infection and community-acquired infection contexts. A total of 1320 prospective stool samples collected on FecalSwab™ (Cary-Blair medium) were screened using BD Max™ CDIFF assay (BDM). Results were compared to the routine algorithm including immunochromatographic testing for glutamate dehydrogenase (GDH) and toxin A/B (tox) using C. DIFF QUIK CHEK COMPLETE® followed by Xpert C. difficile assay in case of GDH+/tox- results. The prevalence of toxigenic C. difficile was estimated to 5.3% (n=70/1320) using the routine algorithm but to 7.4% (n = 98/1320) using BDM. The overall agreement between BDM and the routine algorithm was 97.4%. After resolution of discrepant results between BDM and the algorithm using Xpert C. difficile assay (unless already perform) and toxigenic culture performed by the French National Reference Laboratory, the overall agreement was increased to 99.4%, demonstrating the excellent performances of the test.

Keywords: BD Max; Cary-Blair; Clostridioides difficile; diagnosis; molecular diagnosis.

MeSH terms

  • Bacterial Proteins / analysis
  • Bacterial Toxins* / analysis
  • Clostridioides
  • Clostridioides difficile* / genetics
  • Clostridium Infections* / diagnosis
  • Feces / chemistry
  • Glutamate Dehydrogenase / analysis
  • Humans
  • Prospective Studies
  • Sensitivity and Specificity

Substances

  • Bacterial Proteins
  • Bacterial Toxins
  • Glutamate Dehydrogenase